Prescription drug · NDA
Inomax (Nitric oxide) NDC 64693-003
Nitric oxide 6 mg/L · Gas · Respiratory (Inhalation) · INO Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64693-003-01 | 64693000301 | 78 L in 1 CYLINDER (64693-003-01)Marketed from Jan 17, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Inomax
- Generic name (nonproprietary)
- nitric oxide
- Active ingredients
- Nitric oxide — 6 mg/L
- Dosage form
- Gas
- Route
- Respiratory (Inhalation)
- Labeler
- INO Therapeutics LLCNDC labeler code 64693
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020845
- Marketing start
- Listing expires
- Other FDA classes
- Vasodilation (Physiologic effect)
- Identifiers
- Product ID 64693-003_6fa12acd-30da-4725-953d-68a30b52b66aSPL ID 6fa12acd-30da-4725-953d-68a30b52b66aSPL set ID 762b51be-1893-4cd1-9511-e645fc420d3aRxCUI 582608, 827693UNII 31C4KY9ESH
- Pharmacologic class
- Vasodilator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N464693000301followed by a unit qualifier and the quantityPackage 64693-0003-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INOmax ® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. INOmax is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.…
Excerpt only. Read the full label for complete information.
About NDC 64693-003
- What is NDC 64693-003?
- 64693-003 is the product NDC for Inomax (nitric oxide), Nitric oxide 6 mg/L gas, listed with the FDA by INO Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Inomax (Nitric oxide).
- What is the active ingredient?
- Nitric oxide.
- Who is the labeler?
- INO Therapeutics LLC, NDC labeler code 64693. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Inomax?
- 1 other product NDC are listed under this name. See all Inomax NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Inomax products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Inomaxnitric oxide | Nitric oxide .98 mg/L | GasRespiratory (Inhalation) | INO Therapeutics LLC | 64693-002 | 64693-0002-0164693-0002-02 |
Other NDCs under NDA 020845
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Inomaxnitric oxide | Nitric oxide .98 mg/L | GasRespiratory (Inhalation) | INO Therapeutics LLC | 64693-002 |